The present invention relates to chewable antacid tablet compositions sweetened with aspartame, and preferably sweetened with aspartame and saccharin.
Pharmaceutical compositions, such as antacids, useful for treating upper gastrointestinal tract distress (such as heartburn, indigestion, stomachache, etc.) are widely used. They vary depending on the active ingredients, and increasingly differ in the flavors, texture and even forms. The excipients for such compositions are chosen not only as appropriate for the dose form, but also to provide the best possible aesthetics for the compositions, including texture, flavor, after-taste, etc. A common antacid active ingredient is calcium carbonate.
In spite of the large amount of research directed to providing aesthetically-acceptable antacid tablet compositions containing calcium carbonate for treating upper gastrointestinal distress, there continues to be a need for compositions which have further improvements in aesthetics. Surprisingly, it has been discovered that including the sweetener aspartame (preferably in combination with saccharin) provides chewable calcium carbonate antacid tablets having improved aesthetics.
Thus, it is an object of the present invention to provide chewable calcium carbonate-containing antacid tablet compositions containing a level of calcium carbonate active useful for treating upper gastrointestinal tract distress (e.g., upset stomach, heartburn, indigestion) and sweetened with aspartame which are recognized as having improved aesthetics. Furthermore, an object is to provide methods for treating upper gastrointestinal distress by administering the chewable tablet compositions according to the present invention.
These and other objects of the present invention will become readily apparent from the detailed description which follows.
All percentages and ratios used herein are by weight, and all measurements are made at 25.degree. C., unless otherwise specified.
SUMMARY OF THE INVENTION
The present invention is directed to a chewable calcium carbon- ate-containing antacid tablet composition comprising: (a) a safe and antacid effective amount of calcium carbonate useful for treating upper jastrointestinal tract distress; (b) from about 0.05% to about 1% aspartame, and, optionally, (c) from 0% to about 1% saccharin; and wherein further said composition is in a unit dose form to be totally ingested by chewing.
The present invention is also directed to methods for treating upper gastrointestinal tract distress. These methods comprise orally administering, by chewing, to a human patient in need of such treatment a safe and antacid effective amount of a chewable tablet composition according to the present invention.